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Month: February 2010

On Thursday, March 11, 2010, Jack Garvey, Principal, Compliance Architects LLC, will be presenting an audio conference in conjunction with FXTranslations and FXConferences entitled "Outsourcing and Offshoring in a New Era of FDA Enforcement." This audio conference will... Read more

Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of... Read more

New Jersey based pharmaceutical and medical device companies have a great opportunity this month to gain some significant information on how to improve their compliance outcomes and reduce their costs, using Sharepoint-based quality systems. Sharepoint has become a... Read more

Jack Garvey, Founder of Compliance Architects LLC is Co-Chair of the Bioanalytical Quality Standards Initiative. This initiative, conceived by Synomics Pharma Services, was founded to respond to years of inconsistent guidance and enforcement surrounding bioanalysis in support of... Read more

strat - e - gy [strat-i-jee] - noun skillful use of a stratagem: The salesperson's strategy was to seem always to agree with the customer. a plan, method, or series of maneuvers or stratagems for obtaining a specific... Read more

Scale without cost. These are watchwords to modern business. I want my operations to scale with my business volumes, but I don’t want to add cost -- How can I accomplish this in compliance operations?? Compliance Architects® is... Read more